FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PERIOGRAF DURAPATITE 40-60 MESH
K Number: K840260
·
Decision Apr 5, 1984
Classifications
1
FEI Numbers
96
Registration Numbers
96
Same Product Code
229
Applicant Total
9
Review Days
86
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PERIOGRAF DURAPATITE 40-60 MESH
- K Number
- K840260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.3930
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Sterling Drug, Inc.
- Date Received
- January 10, 1984
- Decision Date
- April 5, 1984
- Product Code
- LYC
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LYC | Bone Grafting Material, Synthetic | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LYC), ordered by most recent decision date.
Bonalive Maxillofacial
FDA 510(k)
FDA Class 2
·Dental
BONTREE PLUS
FDA 510(k)
FDA Class 2
·Dental
FG Bone Graft M
FDA 510(k)
FDA Class 2
·Dental
FG Bone Graft B
FDA 510(k)
FDA Class 2
·Dental
Synthetic Bone Graft Particulate
FDA 510(k)
FDA Class 2
·Dental
CMFlexTM
FDA 510(k)
FDA Class 2
·Dental
Other Clearances by Sterling Drug, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K901369 | GREEN LABEL BIOBRANE II AND RED LABEL BIOBRANE II | Jun 5, 1990 | Substantially Equivalent |
| K896110 | BIOBRANE(R) II | Nov 28, 1989 | Substantially Equivalent |
| K875275 | WINTHROP PHARMACEUTICALS CONTRAST MEDIA WARMER | Jan 27, 1988 | Substantially Equivalent |
| K820164 | EMPTY STERILE CARPUJECT | Feb 24, 1982 | Substantially Equivalent |
| K820023 | CONAGRAF TM DURAPATITE CONES | Feb 24, 1982 | Substantially Equivalent |
| K813257 | ALVEOGRAF DURAPATITE(18-40 MESH) | Jan 5, 1982 | Substantially Equivalent |
| K813070 | PERIOGRAF | Nov 20, 1981 | Substantially Equivalent |
| K780209 | DILUTION SPIKE | Apr 10, 1978 | Substantially Equivalent |